Timing of Inguinal Hernia Repair in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Vanderbilt University
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01678638
First received: August 30, 2012
Last updated: January 20, 2015
Last verified: January 2015
  Purpose

The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.


Condition Intervention
Inguinal Hernia
Premature Birth of Newborn
Procedure: IH repair before NICU discharge
Procedure: IH repair at 55-60 weeks post-menstrual age

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Significant adverse event (SAE) rate [ Time Frame: 9 months beyond NICU discharge ] [ Designated as safety issue: Yes ]
    Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge.

  • Number of hospital days [ Time Frame: From randomization until 9 months post NICU discharge ] [ Designated as safety issue: Yes ]
    Total number of hospital days


Secondary Outcome Measures:
  • Hospital costs [ Time Frame: Enrollment through 9 months after NICU discharge ] [ Designated as safety issue: No ]
    Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.

  • Bayley Scales of Infant Development, 3rd Edition [ Time Frame: 22-26 months corrected age ] [ Designated as safety issue: Yes ]
    Mean BSID scores; primarily cognitive domain


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early inguinal hernia (IH) repair
IH repair before NICU discharge
Procedure: IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
Active Comparator: Late inguinal hernia (IH) repair
IH repair at 55-60 weeks post-menstrual age
Procedure: IH repair at 55-60 weeks post-menstrual age
The IH repair will be performed between 55-60 weeks post-menstrual age.

Detailed Description:

This is a randomized clinical trial comparing early versus late repair in premature infants with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial is defined as the freedom from significant adverse events, a reduction in hospital days during the study period, and normal neurodevelopmental testing at 2 years. Costs of each treatment strategy are also important and are being evaluated.

  Eligibility

Ages Eligible for Study:   up to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant with estimated gestational age < 37 weeks, 0 days
  • In a NICU at participating site
  • Diagnosed with an IH per the pediatric surgery team
  • Parents and providers willing to randomize the infant

Exclusion Criteria:

  • Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is considered a secondary procedure)
  • Known major congenital anomaly that impact neurodevelopmental outcome or chromosomal abnormality
  • Family unable / unwilling to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678638

Contacts
Contact: Martin L Blakely, MD, MS 6159361050 martin.blakely@vanderbilt.edu
Contact: Andfrea Krzyzaniak, MA 6159361050 ext 6071 andrea.krzyzaniak@vanderbilt.edu

Locations
United States, Alabama
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Robert Russell, MD, MPH    205-638-9688      
Principal Investigator: Robert Russell, MD, MPH         
United States, Arkansas
University of Arkansas for Medical Sciences; Arkansas Children's Hospital Not yet recruiting
Little Rock, Arkansas, United States, 72202
Contact: Sid Dassinger, MD    501-364-4000      
Principal Investigator: Sid Dassinger, MD         
United States, California
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's Hospital Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Daniel DeUgarte, MD FACS FAAP    310-206-2429      
Principal Investigator: Daniel DeUgarte, MD FACS FAAP         
University of Southern California Keck School of Medicine; Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Akemi Kawaguchi, MD    323-361-5065      
Principal Investigator: Akemi Kawaguchi, MD         
United States, Michigan
University of Michigan Medical Center; C.S. Mott Children's Hospital Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Steven Bruch, MD, M.Sc    734-764-4151      
Principal Investigator: Steven Bruch, MD, M.Sc         
United States, Minnesota
University of Minnesota Medical School; Amplatz Children's Hospital Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brad Segura, MD, PhD    612-365-6777      
Principal Investigator: Brad Segura, MD, PhD         
United States, Missouri
University of Missouri- Kansas City Medical School; Children's Mercy Hospital Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn St. Peter, MD    816-234-3199      
Principal Investigator: Shawn St. Peter, MD         
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Jacqueline Saito, MD, MSCI    314-454-6022      
Principal Investigator: Jacqueline Saito, MD, MSCI         
United States, North Carolina
Duke University Medical Center; Duke Children's Hospital and Health Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Obinna Adibe, MD    919-681-5077      
Principal Investigator: Obinna Adibe, MD         
United States, Ohio
Ohio State University College of Medicine; Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Katherine Deans, MD, MHSc    614-722-3900      
Principal Investigator: Katherine Deans, MD, MHSc         
United States, Tennessee
University of Tennessee Health Science Center; Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Eunice Huang, MD, MS    901-287-6031      
Principal Investigator: Eunice Huang, MD, MS         
Monroe Carell Jr. Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Martin L Blakely, MD, MS    615-936-1050    martin.blakely@vanderbilt.edu   
Contact: Andrea Krzyzaniak, MA    615-936-1050 ext 6071    andrea.krzyzaniak@vanderbilt.edu   
Principal Investigator: Martin Blakely, MD, MS         
United States, Texas
University of Texas, Southwestern Medical Center; Children's Medical Center Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Diana Diesen, MD    214-730-5437      
Principal Investigator: Li Ern Chen, MD         
Baylor College of Medicine; Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Monica Lopez, MD    832-822-3135      
Principal Investigator: Monica Lopez, MD         
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: KuoJen Tsao, MD    832-325-7234      
Principal Investigator: KuoJen Tsao, MD         
United States, Virginia
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond Not yet recruiting
Richmond, Virginia, United States, 23284
Contact: Jeffrey Haynes, MD FACS FAAP    804-828-3500      
Principal Investigator: Jeffrey Haynes, MD FACS FAAP         
United States, Washington
University of Washington School of Medicine; Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Adam Goldin, MD, MPH    206-987-2794      
Principal Investigator: Adam Goldin, MD, MPH         
United States, Wisconsin
Medical College of Wisconsin; Children's Hospital of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Casey Calkins, MD    414-266-6550      
Principal Investigator: Casey Calkins, MD         
Sponsors and Collaborators
Vanderbilt University
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Martin L Blakely, MD, MS Vanderbilt University
Principal Investigator: Jon E Tyson, MD, MPH University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
  More Information

No publications provided

Responsible Party: Martin Blakely, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01678638     History of Changes
Other Study ID Numbers: 11-225-01
Study First Received: August 30, 2012
Last Updated: January 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
inguinal hernia
premature infants
anesthesia safety
neurodevelopmental outcome
preterm infants
neonatal prematurity

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Premature Birth
Hernia, Abdominal
Obstetric Labor Complications
Obstetric Labor, Premature
Pathological Conditions, Anatomical
Pregnancy Complications

ClinicalTrials.gov processed this record on March 26, 2015